Herbal Drug Regulation and Commercialization: An Indian Industry Perspective

Abstract

Proper implementation of the Drugs and Cosmetics Act of 1940, development of more elaborate guidelines on quality control aspects, and development of marker-based standards are needed to produce safe and effective herbal medicines in India. Because evidence-based studies are becoming increasingly essential for establishing the safety and efficacy of herbal products in the domestic and export market, more focus should be placed on scientific and technological advancement in the field of herbal medicine. Regulatory harmonization becomes essential to mitigate the delays in commercialization across countries.

A study to determine the knowledge and level of awareness of medical undergraduates about herbal medicines and herb-drug interactions

“…The herbal drugs in India are reviewed by the department of Ayush, and do not have a Central drug controlling authority. 19,[28][29][30] Non-centralized non-stringent control may lead to production of sub-standard herbal products by many companies.…”

Revival, modernization and integration of Indian traditional herbal medicine in clinical practice: Importance, challenges and future

“…Following problems need to be overcome before the promotion of traditional herbal knowledge around the world 28, 29, 30, 31, 32, 33, 34

Quality issues : Adulteration, misidentification of plant, faulty collection and preparation, incorrect formulation process are the main problems that reduces the effectiveness of herbal preparation and can be considered as key factors affecting quality and purity of herbal medicines.

Processing and harvesting issues : Indiscriminate harvesting, poor agriculture and propagation method, poor pre and post harvest practices, lack of processing techniques leads to the substandard quality of herbal drugs.

Quality control related issues : Standardization, poor quality control procedure and lack of Good Manufacturing Practices (GMP) are the main hurdle to maintain the quality of herbal drugs.

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Regulatory compliance of herbal medicines – A review

“…Moreover, there are many other countries yet to de ine the regulations. In addition to these hurdles, there are variations in GMP standards in different countries as well (Sahoo and Manchikanti, 2013). (World Health Organization, 2007).…”